Routes of the same type are on the same row. Compare other markets.
12 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, non-prescription monograph, conditional or accelerated approval and more. The table lines up the routes of each type.
Canada: New drug submission (new active substance), 300 days. Taiwan: New indication or new dosage change, 180 days. These are official targets, not actual review times.
| Pathway type | Canada | Taiwan |
|---|---|---|
| Full application, new active substance | New drug submission (new active substance)NDS · target 300 days · fee CA$616,593 | New drug registration, new active substancetarget 360 days · fee NT$1,500,000 Biological product registration (recombinant products, vaccines, plasma products, allergens)target 360 days · fee NT$1,500,000 |
| Full or mixed application, known active substance |
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
New drug registration, known ingredient (new combination, route, dosage form, dose or strength)target 300 days · fee NT$500,000 New indication or new dosage changetarget 180 days |
| Generic application | Abbreviated new drug submission (generic)ANDS · target 180 days · fee CA$71,953 | Generic drug registrationtarget 210 days · fee NT$140,000 |
| Biosimilar application | Biosimilar new drug submissionNDS (biosimilar) · target 300 days | Biosimilar registrationfee NT$1,500,000 |
| Non-prescription application | DIN application with supporting dataDINA / DINB · target 210 days · fee CA$319,282 | - |
| Non-prescription monograph | DIN application under a labelling standard or monographDINA / DINB (labelling standard) · target 60 days · fee CA$1,945 |
| Conditional or accelerated approval | Notice of compliance with conditionsNOC/c · target 200 days | Conditional permit for regenerative medicinal productstarget 120 days · fee NT$1,500,000 New drug accelerated approvaltarget 240 days |
| Approval under exceptional circumstances | - |
| Priority or accelerated review | Priority reviewPriority · target 180 days | New drug priority reviewtarget 240 days Device priority reviewfee NT$180,000 |
| Intensive development support designation | - | Breakthrough therapy designationtarget 240 days |
| Rolling or phased review | - |
| Orphan or rare disease designation | - | Designation for drugs for pediatric or rare severe diseasestarget 240 days |
| Early or compassionate access | Special Access Program (drugs)SAP · relies on EU, US |
| Reliance route, abridged review | Ministerial reliance order (foreign decision deeming)SOR/2026-162 · relies on US, EU, CH, GB, AU | New drug streamlined review (reliance on US, EU and Japan approvals)target 180 days · relies on US, EU, JP |
| Work-sharing or joint review | Access Consortium work sharingNASWSI · target 300 days · relies on AU, SG, CH, GB Project Orbis (cancer drugs)Orbis · relies on US, AU, SG, BR, CH, GB | - |
| Device: exempt or self-declared | - |
| Device: premarket notification | - | Class 1 device listingfee NT$10,000 |
| Device: new low or moderate risk device | - | License for a device with no similar product in Taiwantarget 220 days · fee NT$130,000 License for a world-first devicetarget 365 days · fee NT$250,000 |
| Device: premarket approval by the regulator | Medical device licence, Class IIIMDL Class III · target 60 days · fee CA$30,169 Medical device licence, Class IVMDL Class IV · target 75 days · fee CA$30,713 | Class 3 device licensetarget 200 days · fee NT$100,000 |
| Device: registration or licence with the regulator | Medical device licence, Class IIMDL Class II · target 15 days · fee CA$643 | Class 1 device licensetarget 80 days · fee NT$15,000 Class 2 device licensetarget 140 days · fee NT$58,000 · relies on US, EU In vitro diagnostic device license (Class 2 and Class 3)target 150 days · fee NT$100,000 |
| Other route |